Adults with psychosis who have dependent children aged 2-12 years old Mental and Behavioural Disorders
Conditions
Interventions
Following baseline assessment, participants (parents, n = 75) will be allocated in random permuted blocks using an online service (REDCap) to either Triple P plus TAU or TAU only. Allocation will be i
Sponsors
University of Manchester
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for the feasibility randomized controlled trial (RCT): 1. Aged 18 years or over 2. Parent of child aged 2–12 years with whom they live, or have parental responsibility 3. Experienced at least one episode of non-affective psychosis after the age of 18 years 4. Under the care of an adult mental health team within the participating trusts 5. With sufficient English fluency to engage with intervention and complete assessments 6. Capable of giving informed consent Inclusion criteria for the nested qualitative study with RCT participants: 1. Participated in the feasibility RCT 2. Capacity and willingness to provide informed consent Inclusion criteria for nested qualitative study with NHS professionals (care coordinators): 1. Named care coordinator of a parent participant 2. Employed by GMMH or PCFT 3. Capacity and willingness to provide informed consent
Exclusion criteria
Exclusion criteria: Parents: 1. Inpatient at the time of recruitment 2. Diagnosis of postpartum psychosis without an existing or subsequent diagnosis of psychosis 3. Judged by the assigned care coordinator/responsible clinician and the research team as not being sufficiently clinically stable to engage safely in a clinical trial (e.g. in a current mental health crisis; acutely suicidal; not in stable housing) Nested qualitative study RCT participants: 1. Unwilling or unable to provide consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The feasibility of delivering a full-scale, assessor-blind, randomised controlled trial within adult mental health services in the future regarding: 1. Recruitment: Number of potential participants referred to the study and percentage of those who consent to take part (target sample = 75) at baseline 2. Retention: Percentage of participants retained to 16-week follow-up (target = 70%) 3. Engagement with intervention: Percentage of participants who complete at least half of the Triple P programme within 15 weeks. Data on differential engagement (workbook versus online format Triple P) will also be reported. 4. Outcome completion: Percentage completion of the candidate primary outcome measure (Parenting Stress Index) at 16 weeks 5. Risk: Number and type of adverse events identified by or reported to the research team from baseline to 39 weeks 6. The measurement of health economic outcomes in a future definitive trial using two quality of life and health economic measures (described in the secondary outcome measures below) 7. Sample size calculations for a future larger scale trial informed by examining the 'promise of efficacy' of Triple P on important quantitative clinical outcomes (outlined below) at the 16-week and 39-week follow-up and the variance of these outcomes | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Acceptability of the intervention: measured using qualitative interviews with parent participants and health professionals and questionnaires with parents between 16 and 39 weeks. Interview topic guides contain a priori themes relating to acceptability, for example, the degree of support required for parents to engage with Triple P successfully. Data from a post-randomisation satisfaction survey and a post-intervention client satisfaction questionnaire will also be examined. 2. Clinical outcome measures: a range of validated questionnaires and assessment tools, chosen according to their psychometric properties and widespread use in relevant research will be conducted by research assistants blind to treatment allocation after randomisation. As follows: 2.1. Parenting stress is measured using the Parenting Stress Index (PSI) at baseline, 16 weeks, 26 weeks and 39 weeks 2.2. Parenting efficacy is measured using the Child Adjustment and Parenting Efficacy Scale (CAPES) at baseline, 16 weeks, 26 weeks and 39 weeks 2.3. Parental Mental Health is measured using the Positive and Negative Syndrome Scale (PANSS) at baseline, 16 weeks and 39 weeks 2.4. Parental well-being is measured using the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) at baseline, 16 weeks and 39 weeks 2.5. Child behaviour and well-being are measured by the Strengths and Difficulties Questionnaire (SDQ) at baseline, 16 weeks and 39 weeks 2.6. Quality of life is measured using the Recovering Quality of Life (ReQoL) and European Quality of Life (EQ-5D-5L) scales at baseline, 16 weeks and 39 weeks | — |
Countries
England, United Kingdom
Contacts
Public ContactLynsey Gregg
Outcome results
None listed